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R-016: Placebo-controlled trial of cytisine for smoking cessation

Field Value
Research ID R-016
Authors West R, Zatonski W, Cedzynska M, et al.
Year 2011
Journal / publisher New England Journal of Medicine
DOI 10.1056/NEJMoa1102035
PMID Not reported
ISBN Not reported
Research type Randomized Controlled Trial (single-center, double-blind)
Evidence strength Strong
Population 740 adult daily smokers in Poland
Intervention Cytisine 25-day course (1.5 mg tablets, tapering schedule)
Comparator Placebo
Last verified 2026-10-04

Main question

Is cytisine more effective than placebo for smoking cessation?

Main findings

Cytisine significantly increased 12-month continuous abstinence versus placebo (8.4% vs 2.4%).

Limitations

Single country/center; low absolute quit rates; cytisine was inexpensive relative to alternatives.

Why this record matters

Landmark trial establishing cytisine efficacy; foundation for subsequent cytisine-vs-NRT comparisons.

Cytisine; Quit Smoking Medications

Source

https://www.nejm.org/doi/full/10.1056/NEJMoa1102035